The Meals and Drug Administration (FDA) has cleared the Visby Medical Sexual Well being Take a look at, a polymerase chain response (PCR) diagnostic take a look at for the detection of sexually transmitted infections (STIs) attributable to Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis in ladies.
The one-use, point-of-care take a look at delivers leads to beneath half-hour utilizing patient-collected feminine vaginal swab specimens. The system consists of the Visby Medical Sexual Well being machine, the Visby Medical energy provide, the Visby Medical Vaginal Specimen Assortment equipment, and fixed-volume switch pipettes.
The FDA clearance was based mostly on knowledge from a multicenter research (ClinicalTrials.gov Identifier: NCT04098900) that evaluated the efficiency of the Visby Medical Sexual Well being Take a look at in feminine members 14 to 80 years of age. Amongst sufferers with evaluable outcomes (n=1532), the take a look at confirmed sensitivity of 97.6% (95% CI, 93.2-99.2) and specificity of 98.3% (95% CI, 97.5-98.9) for C. trachomatis (n=1457), sensitivity of 97.4% (95% CI, 86.5-99.5) and specificity of 99.4% (95% CI, 98.9-99.7) for N gonorrhoeae (n=1468), and sensitivity of 99.2% (95% CI, 95.5-99.9) and specificity of 96.9% (95% CI, 95.8-97.7) for T vaginalis (n=1449).
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“By offering a immediate and correct take a look at consequence, the usage of this take a look at will decrease the probability that an contaminated affected person will develop pelvic inflammatory illness,” mentioned Gary Schoolnik, MD, an infectious illness knowledgeable, Chief Medical Officer at Visby Medical, and Professor of Medication at Stanford College. “It’s going to expedite the therapy of that affected person’s sexual companion, and it’ll cut back the unfold of sexually transmitted infections total.”
The take a look at will solely be obtainable in CLIA-waived point-of-care settings.
References
- Visby Medical™ receives FDA clearance and CLIA waiver for second era sexual well being take a look at for ladies. Information launch. Visby Medical. March 14, 2023. https://www.prnewswire.com/news-releases/visby-medical-receives-fda-clearance-and-clia-waiver-for-second-generation-sexual-health-test-for-women-301771495.html.
- Morris SR, Bristow CC, Wierzbicki MR, et al. Efficiency of a single-use, fast, point-of-care PCR machine for the detection of Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis: a cross-sectional research. Printed on-line November 23, 2020. The Lancet Infectious Illnesses. doi.org/10.1016/S1473-3099(20)30734-9
- Visby Medical Sexual Well being Level-of-Care Directions for Use. Visbymedical.com. Accessed March 14, 2023. https://www.visbymedical.com/sexual-health-test/Visby-Medical-Sexual-Well being-Level-of-Care-Directions-for-Use.pdf.
This text initially appeared on MPR
